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Year: 2021

Clinical Activity of AGEN1181 Demonstrated Across Nine Treatment-Resistant Cancers at SITC

Seventeen objective responses reported across nine cancers Evidence of monotherapy activity, with four cases of confirmed objective response Objective responses noted in treatment refractory, poorly immunogenic tumors including microsatellite stable (MSS) colorectal cancer, ovarian cancer, MSS endometrial cancer, and melanoma; as well as responses in tumors not previously reported including pancreatic cancer, cervical cancer, visceral angiosarcoma, non-small cell lung cancer, and leiomyosarcoma No cases of hypophysitis, pneumonitis, or high-grade hepatitis Phase 2/3 trials to be initiated in colorectal and gynecological cancersLEXINGTON, Mass., Nov. 12, 2021 (GLOBE NEWSWIRE) — Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, adjuvants, and vaccines designed to activate immune...

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Apellis Reiterates Plans to Submit a New Drug Application in the First Half of 2022 for Pegcetacoplan for Geographic Atrophy Following FDA Feedback

WALTHAM, Mass., Nov. 12, 2021 (GLOBE NEWSWIRE) — Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that it received formal, written feedback from the U.S. Food and Drug Administration (FDA) that further reinforces the company’s plans to submit a New Drug Application (NDA) for intravitreal pegcetacoplan for geographic atrophy (GA) secondary to age-related macular degeneration. The NDA will be supported by efficacy and safety data from the Phase 3 DERBY and OAKS studies and the Phase 2 FILLY study. In the written feedback, the FDA stated that they do not make a distinction between Phases, provided a clinical trial is adequate and well controlled, and that all three studies appear to be adequate and well controlled. Based on this feedback, Apellis remains on track to submit an NDA in the first half of 2022 and believes...

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Onex Reports Third-Quarter 2021 Results

All amounts in U.S. dollars unless otherwise stated TORONTO, Nov. 12, 2021 (GLOBE NEWSWIRE) — Onex Corporation (TSX: ONEX) today announced its financial results for the third quarter and nine-months ended September 30, 2021, and an update on matters following quarter end. “It was a very active quarter for Onex with strong momentum across all businesses. Investing capital per share grew by 8% and, within our private equity platform, fund performance was strong and capital deployment was focused within our target verticals,” said Gerry Schwartz, Chairman and Chief Executive Officer of Onex. “As we said at our recent Investor Day, we have the people, strategy and culture in place to succeed and feel confident in our ability to accelerate growth and deliver strong results.” HighlightsOnex reported total segment net earnings for...

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Akouos Reports Third Quarter 2021 Financial Results and Provides Business Highlights

– Continued progress toward planned IND submissions for AK-OTOF in the first half of 2022 and AK-antiVEGF in 2022 – Expanded leadership team with appointment of Stacy Price as chief technical officer BOSTON, Nov. 12, 2021 (GLOBE NEWSWIRE) — Akouos, Inc. (Nasdaq: AKUS), a precision genetic medicine company dedicated to developing potential gene therapies for individuals living with disabling hearing loss worldwide, today reports financial results for the third quarter ended September 30, 2021, and provides business highlights. “This quarter we advanced our lead programs, AK-OTOF and AK-antiVEGF, toward planned 2022 IND submissions, and we continue to apply our genetic medicines platform to the discovery and research of additional potential therapies for inner ear conditions,” said Manny Simons, Ph.D., M.B.A., co-founder,...

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Cipher Mining Provides Third Quarter 2021 Business Update

Completed Listing on Nasdaq (CIFR), Raising Net Proceeds of $391 Million Executing Plan to Develop and Deploy Five Bitcoin Mining Data Centers in 2022 Entered Five Year+ Power Purchase Agreements at Compelling Avg. Price of 2.72 cents per kWh Signed Purchase Agreements for Mining Rigs Capable of up to 19.5 Exahash per Second NEW YORK, Nov. 12, 2021 (GLOBE NEWSWIRE) — Cipher Mining, Inc. (NASDAQ: CIFR) (“Cipher” or the “Company”), a U.S.-based Bitcoin mining company, today announced results for its third quarter ended September 30, 2021 with an update on its operational implementation plan and strategy. “As a newly formed public company, I am proud to say we are making great strides in putting in place the essential building blocks for a premier North American Bitcoin mining enterprise,” said Tyler Page, CEO of Cipher. “We have...

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Medicenna Reports Second Quarter Fiscal 2022 Financial Results and Operational Highlights

— Phase 1/2 ABILITY Study of MDNA11 on track for preliminary data updates in calendar 2021 and mid-calendar 2022 — Management hosting conference call and webcast today at 8:30 am ET TORONTO and HOUSTON, Nov. 12, 2021 (GLOBE NEWSWIRE) — Medicenna Therapeutics Corp. (“Medicenna” or “the Company”) (NASDAQ: MDNA TSX: MDNA), a clinical stage immuno-oncology company, today provided a business update and announced its financial results and operational highlights for the quarter ended September 30, 2021. All dollar amounts are in Canadian currency unless otherwise noted. “Our accomplishments over the past few months have laid the foundation towards achieving key milestones that intend to provide the first set of human data of MDNA11 with the aim to show differentiated and potentially superior clinical activity of our lead IL-2...

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HCW Biologics Reports Third Quarter Financial Results and Recent Business Highlights

MIRAMAR, Fla., Nov. 12, 2021 (GLOBE NEWSWIRE) — HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), an innovative biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between chronic, low-grade inflammation and age-related diseases, today reported recent business highlights and financial results for its third quarter ended September 30, 2021. “The third quarter of 2021 and recent weeks were an important period for HCW Biologics and our strategy to build a pipeline of first-in-class immunotherapeutic treatments for age-related diseases,” stated Hing C. Wong, Ph.D., founder and CEO of HCW Biologics Inc. “The third quarter provided bookends to what has been a busy time for the Company. In July, we closed our initial public offering and...

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Sangoma Announces First Quarter Fiscal 2022 Results

Quarterly Revenue Double that of Last Year MARKHAM, Ontario, Nov. 12, 2021 (GLOBE NEWSWIRE) — Sangoma Technologies Corporation (TSX:STC), a trusted leader in delivering cloud-based Communications as a Service solutions for companies of all sizes, today announced highlights of its unaudited results for the first quarter of fiscal year 2022 ended September 30, 2021. Sales for the first quarter of fiscal 2022 were a record $52.48 million, twice that of the same quarter last year and 5% higher than in the last quarter of fiscal 2021. Please note that these results are being presented in United States dollars for the first time, and so all comparable numbers have been converted to US dollars.                 US $M Q1 FY2022 Q1 FY2021 Change Q4 FY2021 ChangeSales $52.48   m $26.22   m 100% $50.12   m 5%Gross profit $37.85   m $17.31   m 119% $35.89   m 5%Operating...

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Xtant Medical Announces Third Quarter 2021 Financial Results

BELGRADE, Mont., Nov. 12, 2021 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE American: XTNT), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today reported financial and operating results for the third quarter ended September 30, 2021. Third Quarter 2021 Financial Highlights:Revenue for the third quarter of 2021 totaled $13.8 million, compared to $14.0 million for the prior-year period Loss from operations totaled $1.4 million compared to operating income of $0.8 million for the prior-year period Net loss incurred in the third quarter of 2021 totaled $1.8 million compared to a net loss of $1.4 million for the prior-year period Non-GAAP Adjusted EBITDA for the third quarter of 2021 totaled a loss of $0.5 million, compared to Non-GAAP Adjusted EBITDA of $1.5 million...

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Bio-Path Holdings Reports Third Quarter 2021 Financial Results

Conference Call to be Held Today at 8:30 A.M. ET HOUSTON, Nov. 12, 2021 (GLOBE NEWSWIRE) — Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced its financial results for the third quarter ended September 30, 2021 and provided an update on recent corporate developments. “The clinical and regulatory advances made during the third quarter position us to initiate two key trials with prexigebersen-A in solid tumors and BP1002 in relapsed/refractory acute myeloid leukemia (AML) patients,” stated Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. “Looking to the balance of the year, we look forward to presenting safety and preliminary efficacy...

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